The Study of Acupuncture on Vascular and Functional Neuroimaging in Parkinson's Disease Patients With Sleep Disorders

NCT03501004 | Completed

• 1 other identifier: QHDXYQYY20180001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare vascular and functional neurological changes of acupuncture in patients with Parkinson's Disease and Sleep Disorders. In the randomized controlled clinical trial study, patients meeting the criteria for inclusion will be randomly enrolled and divided into two groups in a 1:1 ratio: the acupuncture group and the sham acupuncture group. The intervention is going to be executed using the acupoints GV14（Dazhui）and GB20 (Fengchi).The acupuncture needles will be inserted to a depth of 0.8 to 1 cm using GV14（Dazhui）and GB20 (Fengchi) in the acupuncture group. The sham acupuncture group's needles will be inserted to a depth of 0.1 to 0.2 cm with nonacupuncture points located 0.5 cm in lateral to the real acupoint or to the right for midline points.During the study, researchers will observe changes in cerebral blood vessels and neuroimaging before and after acupuncture in the two groups. Using multimodal fusion advanced vascular-neuronal imaging techniques could evaluate the effect of acupuncture on brain blood vessels and function in patients with Parkinson's disease and Sleep Disorders and provide an objective neuroimaging basis for assessing the effectiveness of acupuncture.

Conditions

Acupuncture; Parkinson's Disease; Sleep Disorders; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• Cerebral blood flow data change

  Neuroimaging assessment by 3D SNAP-MRA

  Through once acupuncture completion, 30 minutes

Secondary Outcomes (4)

• Parkinson's Disease Sleep Scale

  Through once acupuncture completion, 30 minutes

• Pittsburgh Sleep Quality Index

  Through once acupuncture completion, 30 minutes

• Epworth Sleepiness Scale

  Through once acupuncture completion, 30 minutes

• Unified Parkinson's Disease Rating Scale

  Through once acupuncture completion, 30 minutes

Study Arms (2)

The Acupuncture Group

EXPERIMENTAL

Sterile acupuncture needles for single use will be used.The intervention is going to be executed using the acupuncture points GV14（Dazhui）and GB20 (Fengchi) for 20 minutes.The acupuncture needles will be inserted to a depth of 0.8 to 1 cm using GV14（Dazhui）and GB20 (Fengchi).

Device: Sterile acupuncture needles for single use

The Sham Acupuncture Group

SHAM COMPARATOR

Sterile acupuncture needles for single use will be used.The sham acupuncture group's acupuncture needles will be inserted to a depth of 0.1 to 0.2 cm with nonacupuncture points located 0.5 cm in lateral to the real acupoint or to the right for midline points for 20 minutes.

Device: Sterile acupuncture needles for single use

Interventions

Sterile acupuncture needles for single use DEVICE

Sterile acupuncture needles for single use are made by China Beijing Zhongyan Taihe Medical Instrument Limited Company.Acupuncture needles' specifications are 0.25mm\*25mm.

The Acupuncture Group; The Sham Acupuncture Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meeting the above diagnostic criteria for Parkinson's disease and Sleep Disorders;
• Hoehn-Yahr grade 2-3;
• Those who voluntarily participate in the project while he/she or his/her guardian sign an informed consent form;
• Those who have had a junior high school education or above and have a correct understanding of clinical acupuncture research significance.

You may not qualify if:

• Accompanied with sleep apnea syndrome, sleep-behavioral disorders such as sleep-breathing disorders, and other system diseases that cause sleep disorders, such as anemia and other hematological diseases, hypothyroidism, severe heart and lung diseases, tumors, liver and kidney diseases;
• History of drug use or alcohol addiction, psychosis and sedation for painful illnesses;
• Severe cognitive impairments and failure to complete scale assessments;
• There are barriers to communication and communication that affect the evaluation of research, such as speech, vision, hearing and other serious damage to patients;
• Allergic to needles or alcohol;
• Those who cannot perform MRI scans, such as claustrophobia.

Sponsors & Collaborators

• Tsinghua University: lead

Study Sites (1)

Tsinghua University Yuquan Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Parkinson Disease; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Yuqi Zhang

  Tsinghua University Yuquan Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: April 18, 2018
• Study Start: June 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: September 30, 2020
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 12 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations

CN (1)